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Table 3 Participant timeline

From: The INVENT COVID trial: a structured protocol for a randomized controlled trial investigating the efficacy and safety of intravenous imatinib mesylate (Impentri®) in subjects with acute respiratory distress syndrome induced by COVID-19

Study period

Screening

Baseline

Treatment

Follow-up

Study day (± window)

0-1

1

2

3

4

5

6

7

10

11-27

28 (±3)

ELIGIBILITY

           

(Deferred) Informed consent

X

          

Demographics

X

          

Relevant medical history

X

          

SARS-CoV-2 diagnostic test review

X

          

Assess ARDS diagnosis and severity

X

          

Inclusion and exclusion criteria

X

          

STUDY INTERVENTION

           

Randomization

 

X

         

IMP administration

 

X

X

X

X

X

X

X

   

Treatment with SoC

X

X

X

X

X

X

X

X

X

X

X

STUDY PROCEDURES

           

12-lead Electrocardiogram

X

X

X

 

X

  

X

X

  

Height and weight

 

X

      

X

  

Targeted physical examination

 

X

X

X

X

X

X

X

   

Vital signs: temperature, pulse rate, blood pressure, respiratory rate, SpO2 and FiO2

X

X

X

X

X

X

X

X

X

  

Placement of central venous catheter and PiCCO catheter

X

          

EVLWi and PVPi

 

X

X

 

X

  

X

   

Mechanical ventilation parameters(i)

 

X

X

 

X

  

X

X

 

X

Arterial blood gas

 

X

X

 

X

  

X

X

  

SOFA score and OI

 

X

X

 

X

  

X

X

 

X

Clinical status

 

X

X

X

X

X

X

X

X

 

X

PK sampling

 

X

X(m)

 

X(m)

  

X(m)

   

Blood, plasma and serum sampling for biomarker studies

 

X

X

 

X

  

X

X

  

Thoracic ultrasound (optional)

 

X

  

X

  

X

   

Targeted medication review (including use of vasopressors)

 

X

X

X

X

X

X

X

 

X

X

Adverse event evaluation

 

X

X

X

X

X

X

X

X

X

X

SAFETY LABORATORY

           

Hematology, chemistry, liver function tests, coagulation

X

X

X

 

X

  

X

X

  

Pregnancy test for females of childbearing potential

X